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Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
Sponsor: Pharvaris Netherlands B.V.
Summary
This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release (XR) Tablet for Prophylaxis and Deucrictibant Immediate-release (IR) Capsule for On-demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-10-16
Completion Date
2027-06
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
Deucrictibant
Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use
Placebo
Part 1: Placebo Comparator tablet for once daily oral use
Deucrictibant
Part 2: Deucrictibant 20 mg soft capsule oral use
Placebo
Part 2: Placebo Comparator soft capsule oral use
Deucrictibant
Part 3: Deucrictibant 20 mg soft capsule oral use
Locations (7)
Study Site
Walnut Creek, California, United States
Study Site
St Louis, Missouri, United States
Study Site
Edmonton, Canada
Study Site
Cambridge, United Kingdom
Study Site
Leicester, United Kingdom
Study Site
London, United Kingdom
Study Site
Plymouth, United Kingdom